Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
Study NCT ID:
NCT00002061
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007542', 'term': 'Inosine Pranobex'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1989-06', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['T-Lymphocytes', 'Immune Tolerance', 'Inosine Pranobex', 'Killer Cells', 'T-Lymphocytes, Helper-Inducer', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex'], 'conditions': ['Lymphatic Disease', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunologic parameters:\n\n* Increase in natural killer (NK) cell activity.\n* Increase in total T-cells (OKT-11).\n* Increases in absolute number and percentages of T-helper cells (OKT-4).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Exclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.\n* Lymphoid malignancy.\n* Infectious mononucleosis caused by cytomegalovirus (CMV) or Epstein-Barr virus (EBV).\n* Heart disease (especially if receiving cardiac glycosides).\n* Hemophilia.\n\nPatients with the following are excluded:\n\n* Kaposi's sarcoma or overt opportunistic infections.\n* Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophile test (EBV) or cell culture (CMV).\n* A history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.\n* Critical illness.\n* Condition requiring hospitalization.\n* Women of childbearing age are excluded.\n\nPrior Medication:\n\nExcluded:\n\n* Steroids, cytotoxic immunosuppressive agents.\n* Antiviral medicine.\n* Excluded within 1 month of study entry:\n* Immunomodulators (including Isoprinosine).\n\nPrior Treatment:\n\nExcluded:\n\n* Radiotherapy.\n\nPatients who have unexplained immunodepression and are at risk of developing AIDS.\n\n* Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).\n\nIV drug abuse."}, 'identificationModule': {'nctId': 'NCT00002061', 'briefTitle': 'A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy', 'orgStudyIdInfo': {'id': '008B'}, 'secondaryIdInfos': [{'id': 'ISO-105-USA'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Inosine pranobex', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92656', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Newport Pharmaceuticals International Inc', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newport Pharmaceuticals International', 'class': 'INDUSTRY'}}}}